Glass containers, with their inherent fragility, sharp edges after fracture, and possibility of introducing fragments into the contents of the container, are increasingly being replaced by plastic containers. Containers made of such materials as polyethylene, polypropylene, and polyvinyl chloride are frequently utilized, and are generally produced by a process of “blow-fill-seal” (BFS), in which the containers are mechanically blow molded, filled, and then sealed in a continuous operation.
BFS containers typically comprise a main chamber, holding the desired contents, and a head portion. A relatively narrow neck forms an outlet channel from the main chamber into the head portion, and this outlet channel is sealed by a frangible membrane that is typically formed by placing a crimp across the head portion during the molding and sealing process. At the time of use, the head portion is broken away from the main chamber portion, thus opening the outlet channel and allowing removal of the contents. A prototypical example of a BFS container is seen in U.S. Pat. No. 4,995,519 to Rose, et al. Alternatively, other methods of sealing the container, such as a foil membrane with a pull-tab, may be used to seal the container, as seen in U.S. Pat. No. 6,357,626 to Zhang, et al.
BFS containers, since they are not typically resealable, have found special application in dispensing unit dose contents, particularly unit dose liquid medicaments. Typical of such use is U.S. Pat. No. 6,241,124 to Hoyt. The '124 device is specifically designed to handle sterile, preservative-free formulations, such as those used in single dose eye drop applications.
While representing a definite advance in packaging, BFS containers as they are currently manufactured share a number of drawbacks. As they are generally designed to handle unit dose, or otherwise small quantities of material, they are generally small, slippery, and difficult to handle. Their small size makes it very difficult to engrave or affix indicia that adequately describe the contents in a size that may readily be discerned by the human eye. In particular, persons with presbyopia or diminished vision generally have a very difficult time reading the small print generally present on such containers. Additionally, the materials from which these containers are compounded are often permeable to inks, adhesives, or other substances such that labeling indicia cannot be imprinted on the container, or even sometimes on labels affixed to the container, without potentially contaminating the contents. Because of the commonality of many BFS container designs, these containers tend to look very much alike, creating dangerous points of confusion in utilizing such containers.
Recent developments in safety labeling have compounded some of the problems associated with BFS containers. There is an increasing trend toward labeling various materials, in particular drugs, with machine-readable codes, more commonly known as bar codes.
A typical system of utilizing bar codes to track, in this case, drugs, is seen in U.S. Pat. No. 5,845,264 to Nelhaus. In the '264 device, machine readable bar codes are placed on various medications, which may be read by a scanner and compared with a computer database of drug information. When combined with bar codes associated with individual persons, pharmacies, or caregivers, discernment and comparison of the various bar codes can be used to generate a plurality of information regarding drug administration. In particular, drug administration can be regulated to minimize the chances of incorrect drug administration, which is widely recognized to be a significant factor in medical treatment related morbidity and mortality.
However, attaching bar codes to BFS containers has proven problematic. The BFS containers are themselves often small, and it is difficult to encode sufficient machine-readable code in a small space to be useful. This is compounded by the necessity of sharing space on the container with visually discernable printing, which must not be covered or otherwise obscured by the machine-readable code. The attachment of an opaque, or even translucent, label, may tend to obscure the contents of the container. Because of the problems of substance migration through BFS packaging, it is often not practical to print bar codes directly on the containers, or even on labels affixed directly to the containers, and heretofore there has been no other practical place to put such code.
Accordingly, what the art has needed is a single-use container and storage apparatus designed to incorporate a labeling portion to safely and reliably bear indicia, without minimizing or obscuring the labeling on such containers. The labeling portion should be functionally separated from those parts of the walls of the BFS container which enclose the contents of the container in order to prevent migration of substances incidental to labeling through the walls of the BFS container and into the container contents, and yet be physically part of the BFS container in order to prevent separation of the labeling from the container. The containers should be distinctive in appearance, and should be simple and inexpensive to manufacture with a minimum of fabrication steps. The instant invention answers these, and other, needs.